MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE L; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142120490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation; however, photos were provided by the customer.Investigation is pending.
Event or Problem Description
The event occurred on an unspecified date and involved a primary plum y-type blood set, 200 micron filter, clave secondary port, secure lock, 110 inch, where it was reported a nurse was attaching a syringe to the blue clave that's bonded to the cassette, and the small hard plastic tube between the clave and cassette snapped off.The registered nurse stated it snapped off easily when she started twisting on the syringe.The event occurred during infusion; the nurse was setting up the flush so the patient could receive the last 20 ml of product.The nurse quickly disconnected the tubing from the patient.The patient was just not able to receive the last 20 ml of their transfusion.There was patient involvement, and it was unknown if there was patient harm as the incident resulted in an open line to the patient¿s vein.Moreover, there was no delay in critical therapy.
Additional Manufacturer Narrative
Received two photos from the customer showing the clave broken from the secondary port of the cassette.The shape of the deformation was angled where one sided is higher than the other, typical of a bend break.The reported complaint on the 142120490 primary plum y-type blood set can be confirmed.The probable cause is due to an unintentional bending force during use.The device history review (dhr) for lot 13702513 was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, SECURE L
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18445887
• Report Number: 9615050-2024-00014
• Device Sequence Number: 6883487
• Product Code: FPA
• UDI-Device Identifier: 10887787006428
• UDI-Public: (01)10887787006428(17)260801(10)13702513
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: 142120490
• Device Lot Number: 13702513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLUSH, UNK MFR; SYRINGE, UNK MFR; UNSPECIFIED SOLUTION,
• Patient Sex: Unknown